BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1191208 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04880
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILATATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. HOWEVER, LOT NUMBER 581863, PROVIDED BY THE COMPLAINANT REPRESENTS THE PROLIEVE CATHETER CONTAINED IN THE PROLIEVE THERMODILATATION KIT. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2008-04881 FOR A DESCRIPTION OF THE SECOND DEVICE. A PROLIEVE THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO PLACE THE CATHETER PROPERLY. THE PROLIEVE CATHETER BUCKLED UP DURING PLACEMENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PT COMPILATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR